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510(k) K823124

IMS HEMATOLOGY MIXER by Innovative Medical Systems, Inc. — Product Code GLE

K823124 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "IMS HEMATOLOGY MIXER". The FDA issued a decision of Substantially Equivalent on November 22, 1982. The device falls under product code GLE (Mixer, Blood Tube), a Class I device regulated under 21 CFR 862.2050. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1982
Date Received
October 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Blood Tube
Device Class
Class I
Regulation Number
862.2050
Review Panel
CH
Submission Type

Other clearances by Innovative Medical Systems, Inc.

  • K973035 — VIOLA II DENTAL CAMERA SYSTEM (September 24, 1997)
  • K951469 — BAZOOKA SYSTEM (June 28, 1995)
  • K933184 — POSITIVE AIRWAY PRESSURE SYSTEM (November 28, 1994)
  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K922081 — LABOTECH AUTOMATED MICROTITER ANALYZER (September 2, 1992)
  • K921005 — AUTOLOADER (April 29, 1992)
  • K915457 — PHACO 20/20 SYSTEM I (February 24, 1992)
  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)

Other clearances for product code GLE

  • K800003 — CORTEX DOUBLE HELIX SAMPLER (February 1, 1980)
  • K780544 — DISC-PAK ROTATOR (April 24, 1978)
  • K771617 — SPECI-MIX (September 2, 1977)
  • K770830 — PLATELET AGITATOR (July 11, 1977)

FDA data resources